Clinical Program Quality, Associate Director, R&d, China
Takeda
Shanghai, China
Gcp-related quality assurance
Clinical trial experience
Nmpa/cfdi inspection experience
Provides quality assurance oversight of global and local clinical research programs with the overall goal of inspection readiness
Job Summary
Provides quality assurance oversight of global and local clinical research programs with the overall goal of inspection readiness.
Serves as a Strategic Quality Thought Partner to Clinical Program Teams, providing professional clinical research quality expertise and risk-based advice.
Leads inspection readiness programs, management of inspections, and response/follow-up activities, ensuring communication and mitigation of inspection risks.
Matching Summary
Provides quality assurance oversight of global and local clinical research programs with the overall goal of inspection readiness.
Skills & Requirements
Must-have
GCP-related Quality Assurance
clinical trial experience
NMPA/CFDI inspection experience
ICH GCP knowledge
risk-based program audit strategy
stakeholder management
Nice-to-have
critical thinking skills
creative solutions
negotiate and influence without authority
positive attitude
Key Requirements
BA/BS degree required; advanced degree preferred
Minimum 10 years pharmaceutical/biotech experience
Minimum 7 years GCP Quality Assurance/clinical trial experience